Brain InjuriesNCT00483522
Telephone Intervention After Traumatic Brain Injury
A study testing Self-management telephone counseling in people with Brain Injuries, run by University of Washington at 3 sites in United States.
Trial summary
This study seeks to determine if telephone counseling improves the outcome for persons with moderate to severe traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Brain Injuries
- What is being tested?
- Self-management telephone counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 433 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2004to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- a primary diagnosis of traumatic brain injury upon admission to inpatient rehabilitation
- age 16 years or older
- arrival to an emergency department within 24 hours of acute injury
- receipt of both acute hospital care and inpatient rehabilitation within our facilities
- a permanent home address
Who cannot join
- previous hospitalization for TBI
- acute psychiatric disorder (e.g., schizophrenia or bipolar affective disorder)
- progressive neurological disease
- lack of a permanent home address
- discharge to a skilled nursing facility
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Methodist Rehabilitation Center
Jackson, Mississippi, 39216
Moss Rehabilitation Research Institute
Philadelphia, Pennsylvania, 19141
University of Washington
Seattle, Washington, 98195
About this study
Official title: The Effect of Scheduled Telephone Intervention on Outcomes After Traumatic Brain Injury
This study seeks to determine if telephone counseling improves the outcome for persons with moderate to severe traumatic brain injury (TBI).
Read the detailed description
Subjects are recruited from the three participating TBI Model Systems of Care at Seattle, Philadelphia, and Jackson. After informed consent is obtained, some information is gathered about the injury and information about how the subject is doing cognitively, socially, and emotionally. After this information is obtained and after the subject is discharged from the acute rehabilitation unit, the subject is randomly selected to receive either standard care after discharge or standard care plus the telephone counseling.
The telephone follow-up group receives a telephone call from a research coordinator in 3-4 days, 2, 4, 8 weeks, and 5, 7, 9, 12, 15, 18, and 21 months after the date of injury. The research coordinator will work with the subject on problem-solving and self-management skills. In addition, the research coordinator will check in with a family member or friend for whom the subject has given permission to speak.
An outcome assessment is done by telephone at 12 months and 24 months after injury.
- Conditions
- Brain Injuries
- Being tested
- Self-management telephone counseling
- Keywords
- Rehabilitation, Directive counseling, Brain injuries
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management telephone counselingBehavioural
Subjects are contacted 7 times in year 1 after discharge from hospital rehabilitation unit and 4 times in year 2. Telephone counseling based on a self-management/problem-solving model is conducted by a research care manager.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Scheduled telephone counseling over 2 years time. Receives: Behavioral: Self-management telephone counseling |
| 2 | No intervention | This control group will receive standard care after hospital rehabilitation discharge as directed by their physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being.
Measured: One and two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2007 (estimated)
- Study startDec 2004
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 433 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- Kathleen R Bell, M.D., Principal investigator, University of WashingtonTessa Hart, Ph.D., Study director, Moss Rehabilitation Research InstituteMark Sherer, Ph.D., Study director, Methodist Rehabilitation Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00483522
- Sponsor's protocol ID
- 98-7055-C09
- Status last verified
- Jun 2012
- First submitted
- 5 Jun 2007
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Bell KR, Esselman P, Garner MD, Doctor J, Bombardier C, Johnson K, Temkin N, Dikmen S. The use of a World Wide Web-based consultation site to provide support to telephone staff in a traumatic brain injury demonstration project. J Head Trauma Rehabil. 2003 Nov-Dec;18(6):504-11. doi: 10.1097/00001199-200311000-00004.
PubMed 14707880Bell KR, Hoffman JM, Doctor JN, Powell JM, Esselman P, Bombardier C, Fraser R, Dikmen S. Development of a telephone follow-up program for individuals following traumatic brain injury. J Head Trauma Rehabil. 2004 Nov-Dec;19(6):502-12. doi: 10.1097/00001199-200411000-00007.
PubMed 15602312Bell KR, Temkin NR, Esselman PC, Doctor JN, Bombardier CH, Fraser RT, Hoffman JM, Powell JM, Dikmen S. The effect of a scheduled telephone intervention on outcome after moderate to severe traumatic brain injury: a randomized trial. Arch Phys Med Rehabil. 2005 May;86(5):851-6. doi: 10.1016/j.apmr.2004.09.015.
PubMed 15895327Bell KR, Hoffman JM, Temkin NR, Powell JM, Fraser RT, Esselman PC, Barber JK, Dikmen S. The effect of telephone counselling on reducing post-traumatic symptoms after mild traumatic brain injury: a randomised trial. J Neurol Neurosurg Psychiatry. 2008 Nov;79(11):1275-81. doi: 10.1136/jnnp.2007.141762. Epub 2008 May 9.
PubMed 18469027Bombardier CH, Bell KR, Temkin NR, Fann JR, Hoffman J, Dikmen S. The efficacy of a scheduled telephone intervention for ameliorating depressive symptoms during the first year after traumatic brain injury. J Head Trauma Rehabil. 2009 Jul-Aug;24(4):230-8. doi: 10.1097/HTR.0b013e3181ad65f0.
PubMed 19625862Hart T, Sherer M, Temkin N, Whyte J, Dikmen S, Heinemann AW, Bell K. Participant-proxy agreement on objective and subjective aspects of societal participation following traumatic brain injury. J Head Trauma Rehabil. 2010 Sep-Oct;25(5):339-48. doi: 10.1097/HTR.0b013e3181c7e60b.
PubMed 20042981Bell KR, Brockway JA, Hart T, Whyte J, Sherer M, Fraser RT, Temkin NR, Dikmen SS. Scheduled telephone intervention for traumatic brain injury: a multicenter randomized controlled trial. Arch Phys Med Rehabil. 2011 Oct;92(10):1552-60. doi: 10.1016/j.apmr.2011.05.018.
PubMed 21963122
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Scheduled Telephone Intervention on Outcomes After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT00483522
- Acronym / sponsor ID
- 98-7055-C09
- Conditions
- Brain Injuries
- Keywords
- Rehabilitation, Directive counseling, Brain injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 433 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- Dec 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to determine if telephone counseling improves the outcome for persons with moderate to severe traumatic brain injury (TBI).
Detailed description
Subjects are recruited from the three participating TBI Model Systems of Care at Seattle, Philadelphia, and Jackson. After informed consent is obtained, some information is gathered about the injury and information about how the subject is doing cognitively, socially, and emotionally. After this information is obtained and after the subject is discharged from the acute rehabilitation unit, the subject is randomly selected to receive either standard care after discharge or standard care plus the telephone counseling.
The telephone follow-up group receives a telephone call from a research coordinator in 3-4 days, 2, 4, 8 weeks, and 5, 7, 9, 12, 15, 18, and 21 months after the date of injury. The research coordinator will work with the subject on problem-solving and self-management skills. In addition, the research coordinator will check in with a family member or friend for whom the subject has given permission to speak.
An outcome assessment is done by telephone at 12 months and 24 months after injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Self-management telephone counselingScheduled telephone counseling over 2 years time. |
| 2 | No intervention | –This control group will receive standard care after hospital rehabilitation discharge as directed by their physician. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- a primary diagnosis of traumatic brain injury upon admission to inpatient rehabilitation
- age 16 years or older
- arrival to an emergency department within 24 hours of acute injury
- receipt of both acute hospital care and inpatient rehabilitation within our facilities
- a permanent home address
Key exclusion criteria (5 listed)
- previous hospitalization for TBI
- acute psychiatric disorder (e.g., schizophrenia or bipolar affective disorder)
- progressive neurological disease
- lack of a permanent home address
- discharge to a skilled nursing facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management telephone counselingSubjects are contacted 7 times in year 1 after discharge from hospital rehabilitation unit and 4 times in year 2. Telephone counseling based on a self-management/problem-solving model is conducted by a research care manager. | Behavioural | 1 |
Primary outcome
A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being.
Time frame: One and two years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2012.
- Background: PubMed 14707880Bell KR, Esselman P, Garner MD, Doctor J, Bombardier C, Johnson K, Temkin N, Dikmen S. The use of a World Wide Web-based consultation site to provide support to telephone staff in a traumatic brain injury demonstration project. J Head Trauma Rehabil. 2003 Nov-Dec;18(6):504-11. doi: 10.1097/00001199-200311000-00004.
- Background: PubMed 15602312Bell KR, Hoffman JM, Doctor JN, Powell JM, Esselman P, Bombardier C, Fraser R, Dikmen S. Development of a telephone follow-up program for individuals following traumatic brain injury. J Head Trauma Rehabil. 2004 Nov-Dec;19(6):502-12. doi: 10.1097/00001199-200411000-00007.
- Background: PubMed 15895327Bell KR, Temkin NR, Esselman PC, Doctor JN, Bombardier CH, Fraser RT, Hoffman JM, Powell JM, Dikmen S. The effect of a scheduled telephone intervention on outcome after moderate to severe traumatic brain injury: a randomized trial. Arch Phys Med Rehabil. 2005 May;86(5):851-6. doi: 10.1016/j.apmr.2004.09.015.
- Background: PubMed 18469027Bell KR, Hoffman JM, Temkin NR, Powell JM, Fraser RT, Esselman PC, Barber JK, Dikmen S. The effect of telephone counselling on reducing post-traumatic symptoms after mild traumatic brain injury: a randomised trial. J Neurol Neurosurg Psychiatry. 2008 Nov;79(11):1275-81. doi: 10.1136/jnnp.2007.141762. Epub 2008 May 9.
- Background: PubMed 19625862Bombardier CH, Bell KR, Temkin NR, Fann JR, Hoffman J, Dikmen S. The efficacy of a scheduled telephone intervention for ameliorating depressive symptoms during the first year after traumatic brain injury. J Head Trauma Rehabil. 2009 Jul-Aug;24(4):230-8. doi: 10.1097/HTR.0b013e3181ad65f0.
- Results publication: PubMed 20042981Hart T, Sherer M, Temkin N, Whyte J, Dikmen S, Heinemann AW, Bell K. Participant-proxy agreement on objective and subjective aspects of societal participation following traumatic brain injury. J Head Trauma Rehabil. 2010 Sep-Oct;25(5):339-48. doi: 10.1097/HTR.0b013e3181c7e60b.
- Results publication: PubMed 21963122Bell KR, Brockway JA, Hart T, Whyte J, Sherer M, Fraser RT, Temkin NR, Dikmen SS. Scheduled telephone intervention for traumatic brain injury: a multicenter randomized controlled trial. Arch Phys Med Rehabil. 2011 Oct;92(10):1552-60. doi: 10.1016/j.apmr.2011.05.018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen R Bell, M.D. principal investigator
University of Washington
Tessa Hart, Ph.D. study director
Moss Rehabilitation Research Institute
Mark Sherer, Ph.D. study director
Methodist Rehabilitation Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management telephone counseling in people with Brain Injuries, run by University of Washington at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A composite measure based on the measures of functional level, emotional status, community activities, and perceived quality of well-being. (time frame: One and two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00483522, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2012.